The European Medicines Agency is informing pharmaceutical companies that a new version of the validation criteria for electronic applications for human medicines is coming into effect on Thursday 1 September. The Agency will be applying new electronic common technical document (eCTD) validation criteria (version 3.1) upon technical validation of all eCTD sequences received from this date. The Agency has agreed the new criteria with regulatory authorities in European Union (EU) Member States.
The Agency advises applicants to familiarise themselves with the new criteria. Applications that do not adhere to the new requirements will lead to a negative technical validation.
Release notes and implementation information are available on the telematics implementation group for electronic submission (TIGes) documentation page. The Agency will also publish updated eCTD guidance for industry on this website by the end of August.